FDA.reportPublic FDA data

Cardio Clear

Primary DI
00814907020005
Brand
Cardio Clear
Company
CARDIO-MEDICAL PRODUCTS, INC.
Model
A102
Catalog number
A102
Device description
RadioTransparent Defibrillation Electrodes, Anderson Connector
Published
2015-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDDDc-Defibrillator, Low-Energy, (Including Paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103159000CARDIO MED MODEL A102, H104, O101, P103, AND Z100Cardio Medical Products, Inc.2011-01-11LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814907020002PackageGS110In Commercial Distribution
00814907020005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081490702000210814907020002
00814907020005008149070200058149070200050814907020005

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode, adult, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9735869500info@cardiomedicalproducts.com

Regulatory Flags#

DUNS number
029286150
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814907020029Cardio ClearLTA202LTA2022015-07-28
00814907020036Cardio ClearLOCA502LOCA5022015-07-28
00814907020050Cardio ClearH104H1042015-07-28
00814907020067Cardio ClearP403P4032015-07-28
00814907020074Cardio ClearA402A4022015-07-28
00814907020081Cardio ClearTH204TH2042015-07-28
00814907020098Cardio ClearLTH204LTH2042015-07-28
00814907020104Cardio ClearLTZ200LTZ2002015-07-28
00814907020111Cardio ClearLOCH504LOCH5042015-07-28
00814907020135Cardio ClearO101O1012015-07-28
00814907020142Cardio ClearO101-SO101-S2015-07-28
00814907020159Cardio ClearO401O4012015-07-28
00814907020166Cardio ClearTO201TO2012015-07-28
00814907020173Cardio ClearLTO201LTO2012015-07-28
00814907020180Cardio ClearLOCO501LOCO5012015-07-28
00814907020203Cardio ClearP103P1032015-07-28
00814907020210Cardio ClearH404H4042015-07-28
00814907020227Cardio ClearTP203TP2032015-07-28
00814907020234Cardio ClearLTP203LTP2032015-07-28
00814907020241Cardio ClearLOCP503LOCP5032015-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817392026217UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026224UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026231UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392025647UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025654UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025593UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025609UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
07613365002737Tempus LS-MANUALSchiller AGLDD2020-08-11
08054242441765NAFIAB SPALDD2020-04-12
08054242441772NAFIAB SPALDD2020-04-12
08054242441789NAFIAB SPALDD2020-04-12
08054242441796NAFIAB SPALDD2020-04-12
08054242441802NAFIAB SPALDD2020-04-12
08054242441819NAFIAB SPALDD2020-04-12
08054242441826NAFIAB SPALDD2020-04-12
08054242441833NAFIAB SPALDD2020-04-12
08054242441840NAFIAB SPALDD2020-04-12
08054242441857NAFIAB SPALDD2020-04-12
08054242441871NAFIAB SPALDD2020-04-12
08054242441895NAFIAB SPALDD2020-04-12
08054242444933NAFIAB SPALDD2020-04-12
08054242446425NAFIAB SPALDD2020-04-12
08054242446432NAFIAB SPALDD2020-04-12
08054242446449NAFIAB SPALDD2020-04-12
08054242446456NAFIAB SPALDD2020-04-12